Abilify lawsuits charge Otsuka Pharmaceutical Co. and Bristol-Myers Squibb with being negligent in creating a drug that was defectively designed and manufactured. The companies are accused of knowing about Abilify’s alleged tendency for causing compulsive behaviors, such as binge eating, hypersexual behavior and compulsive spending, and failed to provide adequate instructions and warnings. Nearly 1,600 lawsuits over claims Abilify caused compulsive gambling are pending in federal court in Florida and 100 more cases are pending in state courts.
If you or a loved one suffered from adverse events like compulsive behaviors after Abilify use, you may be eligible for compensation.
Users of the antipsychotic drug Abilify (aripiprazole) are suing drug companies, claiming insufficient warning of Abilify’s tendency to cause compulsive gambling, costing patients thousands of dollars.
Abilify lawsuits generally allege that the drug’s maker, Otsuka Pharmaceutical, and its marketer, Bristol-Myers Squibb, were negligent in creating a drug that was defectively designed and manufactured.
Post-marketing case reports suggest that Abilify users can experience intense urges and the inability to control these urges while taking the drug.
Drug companies have an obligation to inform the public about any harmful side effects of drugs they create and market.
However, prior to May 2016, Abilify’s label did “not entirely reflect the nature of the impulse-control risk” identified by the U.S. Food and Drug Administration, according to a June 2016 FDA safety announcement.
Hundreds of Abilify compulsive gambling lawsuits have been centralized in Florida and consolidated into a multidistrict litigation, or MDL. This can happen when federal lawsuits share similar characteristics.
The first three trials in the MDL had been scheduled in June 2018. But all three settled for undisclosed amounts before the trials started. To date, no global settlement has been announced. U.S. District Judge M. Casey Rodgers has given the parties until Sept. 1, 2018 to finalize the framework of a global settlement.
Abilify litigation is ongoing, and attorneys continue to accept new Abilify cases.
In October 2016, the U.S. Judicial Panel on Multidistrict Litigation consolidated current and future federal Abilify lawsuits into a multidistrict litigation and transferred the MDL to U.S. District Court in the Northern District of Florida.
The goal of an MDL is to streamline court proceedings for many complex federal cases with similar facts and allegations by moving the cases to a single court and appointing one judge to oversee them. The judicial panel chose U.S. District Judge M. Casey Rodgers to preside over the Abilify MDL.
“Plaintiffs in these actions each allege that they experienced compulsive gambling behaviors as a result of taking Abilify,” the panel said in its transfer order.
“All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.”
At the time, 22 Abilify lawsuits were pending in 12 districts. As of June 2018, 1,596 lawsuits remained pending.
The Abilify MDL, officially designated MDL 2734, in re: Abilify Products Liability Litigation, is in the discovery phase, which is a period in the early stages of litigation in which the parties exchange information before trial.
The judge presiding over the federal Abilify litigation and the parties involved chose three cases to serve as bellwethers, with trials scheduled in the summer of 2018. Before trials started, however, those three cases all settled. The terms of the settlements were not disclosed to the public.
You may be eligible for compensation through a lawsuit if you or your loved one used Abilify and experienced harmful compulsive behaviors that resulted in financial, mental and physical damages.
You may be more likely to recover money from Abilify’s makers if you have proof of losing a minimum of $10,000 to compulsive gambling or compulsive spending, or proof of excess weight gain from compulsive eating.
Courts may also award punitive damages against drug companies, which are intended to punish them and ensure that neither they nor other organizations engage in similar behavior in the future.
Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co. Ltd. and Otsuka America Pharmaceutical Inc. are the companies facing lawsuits over Abilify.
The companies are engaged in the development, design, testing, labeling, packaging, promoting, advertising, marketing, distribution and selling of Abilify.
Otsuka Pharmaceutical Co. Ltd. discovered Abilify, which is an atypical antipsychotic prescription medicine. Abilify was first sold in the U.S. in 2002. Bristol-Myers Squibb marketed the drug until 2013.
Lawsuits say Bristol-Myers Squibb and Otsuka knew or should have known that Abilify causes and contributes to an increased risk of uncontrollable compulsive behaviors, such as compulsive gambling.
The companies are accused of designing and manufacturing a defective drug as well as failing to warn, advise, educate or otherwise inform Abilify users or prescribers in the U.S. about the risk of compulsive gambling or other compulsive behaviors.
According to lawsuits, the drug’s U.S. label made no mention of pathological gambling or compulsive behaviors for about 14 years. Yet, labeling in Europe and Canada for the same drug warned about the risk of pathological gambling.
In January 2016, the companies added “pathological gambling” to the Postmarketing Experience section of the U.S. label. However, they made no mention of gambling or compulsive behaviors in the patient medication guide, the source of information most likely viewed by doctors and patients.
People who filed lawsuits against Bristol-Myers Squibb and Otsuka said the drug turned them into compulsive gamblers and sex addicts and ruined their lives. Among those who filed lawsuits are:
In April 2016, Joseph Edgar sued Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co. Ltd. and Otsuka America Pharmaceutical Inc., alleging that he began to gamble compulsively after he began taking Abilify in April 2009. The gambling problems stopped after he stopped taking the drug in April 2014, but he had lost more than $36,000 and faced other mental and physical damages.
A day after Edgar filed suit in Pennsylvania, a woman named Athalean Harper-Mosley filed a similar suit in California. She claims she began taking Abilify in July 2007, incurred gambling losses of more than $65,000 and stopped having impulsivity problems after she stopped taking the drug in May 2014.
Patrick Parks sued Abilify’s makers in November 2016. Parks began taking the drug around May 2013 and “began compulsively gambling shortly thereafter,” his complaint says. He stopped taking Abilify in August 2014 and stopped gambling. But by then he had already lost more than $75,000.
Similarly, Massachusetts resident Rikki Carlson sued Bristol-Myers Squibb, Otsuka Pharmaceutical and Otsuka American Pharmaceutical alleging that after she began taking Abilify in December 2010, she began compulsively gambling, eating and shopping. Those behaviors stopped after she stopped taking the medication in March 2016.
No global settlement has been announced to resolve the hundreds of cases pending under the Abilify MDL.
Chief Judge M. Casey Rodgers, who is overseeing the Abilify MDL proceedings, appointed experienced legal mediator and negotiator Cathy Yanni as the settlement master on Feb. 28, 2017.
Yanni was involved in similar drug and medical device litigation, including transvaginal mesh, the Medtronic Infuse, Avandia heart attacks and Yaz birth control lawsuits.
On May 2, 2018, Rodgers directed the parties to work with Yanni to finalize the framework of a global settlement by Sept. 1, 2018.
Federal Abilify gambling lawsuits are currently consolidated into a multidistrict litigation as opposed to a class action.
This means that individuals who file federal Abilify gambling lawsuits may be eligible for different amounts of compensation. This is unlike class actions, which limit all participants to a single award amount.
Lawyers who handle complex drug litigation tend to not recommend class actions because every member of the class is awarded the same amount of money no matter the seriousness of their injuries.
Although serious side effects of Abilify have been reported in the past, gambling was first mentioned as a side effect in January 2016 when it was added to the Postmarketing Experience section of the label.
Despite warnings and advisories in Europe and Canada for the same drug sold to patients in the U.S., “the labeling for Abilify in the U.S. did not adequately warn about the risk of compulsive gambling and contained no mention that pathological gambling had been reported in patients prescribed Abilify,” according to lawsuits.
Before May 2016, the label did not include warnings for compulsive behaviors other than pathological gambling, and it did not adequately warn patients about the risk of compulsive gambling. Abilify’s makers also neglected to mention gambling in the patient medication guide.
Between 2002 and 2016, the FDA identified 184 case reports in which there was an association between aripiprazole use and impulse-control problems.
Of the compulsive behaviors, pathological gambling was the most common, with 164 cases. The number only includes reports submitted to the FDA; the agency noted that there could be additional cases about which it is not aware.
These compulsive behaviors can affect anyone who is taking the medicine, and, though rare, they may result in harm to the patient and others if not recognized, the FDA said in a May 3, 2016, Drug Safety Communication.
Within seven months of the FDA’s announcement, the number of Abilify gambling lawsuits had grown to more than 40.
From 2005 to 2013, an FDA report showed Abilify accounted for at least 54 reports of compulsive or impulsive behavior problems, including:
As a result of the FDA’s findings, the agency required new warnings in the drug’s label.
The current Abilify label warns that because “patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.”
The label goes on to say that compulsive behaviors may result in harm to the patient and others if not recognized. It advises doctors to “consider dose reduction or stopping the medication if a patient develops such urges.”
Five women sued Bristol-Myers Squibb Co. and Otsuka American Pharmaceutical in 2014 and 2015, alleging Abilify caused Type 2 diabetes in children and that the companies failed to warn physicians who prescribed the drug for off-label use of that risk. Those suits, however, were dismissed. They were all filed in New York, and the defendants successfully argued that they would be unable to get out-of-state witnesses to testify.
A U.S. judge tossed federal-court claims that Bristol-Myers Squibb and Otsuka Pharmaceutical paid kickbacks to persuade doctors to prescribe Abilify. Two whistleblowers brought the lawsuit in 2011, pointing to promotions to pediatric psychiatrists as evidence of off-label marketing. Judge William Bertelsman said in his ruling that there was a lack of specific evidence to support the kickback claims. He did, however, permit the whistleblowers to pursue claims that Bristol-Myers fired them to retaliate for their off-label accusations.
It is not illegal for doctors to prescribe a medication for an unapproved use, but it is illegal for drug companies to encourage doctors to do it. Bristol-Myers Squibb has paid two, multimillion-dollar settlements to resolve allegations that it did just that.
Please seek the advice of a medical professional before making health care decisions.
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